Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-27

Study Completion Date

2017-04-27

Brief Summary

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To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms

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Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IV vortioxetine

Group Type EXPERIMENTAL

Vortioxetine (IV)

Intervention Type DRUG

17 mg, solution for infusion, administered, over 2 hours as single dose

Vortioxetine (tablet)

Intervention Type DRUG

10 mg, tablets, oral administration once daily for 15 days (open labelled)

IV placebo

Group Type PLACEBO_COMPARATOR

Placebo (IV)

Intervention Type OTHER

Saline: isotonic sodium chloride, administered, over 2 hours as single dose

Vortioxetine (tablet)

Intervention Type DRUG

10 mg, tablets, oral administration once daily for 15 days (open labelled)

Interventions

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Vortioxetine (IV)

17 mg, solution for infusion, administered, over 2 hours as single dose

Intervention Type DRUG

Placebo (IV)

Saline: isotonic sodium chloride, administered, over 2 hours as single dose

Intervention Type OTHER

Vortioxetine (tablet)

10 mg, tablets, oral administration once daily for 15 days (open labelled)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patient has recurrent Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM-5™), classification code (296.3x). The recurrent Major Depressive Episode (MDE) should be confirmed using the Mini-International Neuropsychiatric Interview (MINI).
* The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥30 at both Screening and Baseline Visits.
* The patient has had the current MDE for ≥3 months

Exclusion Criteria

* The patient has any current psychiatric disorder or Axis I disorder (DSM-5™ criteria), other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has a current diagnosis of history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-5™ criteria).
* The patient suffers from personality disorders, intellectual disability, pervasive development disorder, attention deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ criteria).
* The patient has a history of lack of response to previous treatment with vortioxetine (including current episode).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No